Detailed Action
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/01/25 and 10/10/22 have been considered by the examiner.
Election/Restriction
Applicant’s election without traverse of Invention II (Claims 28-34 and 39) in the reply filed on 12/01/25 is acknowledged. Invention I (Claims 1-27), Invention III (Claims 35, 36 and 40), Invention IV (Claims 37 and 38) and Invention V (Claim 41) have been withdrawn.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 28-34 are rejected under 35 U.S.C. 102(a)(2) as being unpatentable over Heikenfeld (U.S. Patent Application Document 2024/0215904)
Regarding claim 28, Heikenfeld teaches a method of predicting and/or confirming ovulation of a subject using a system of claim 1 [par. 8, 44], the method comprising; measuring at least one hormone and/or analyte from interstitial fluid of the subject [par. 38]; and measuring a concentration change of luteinizing hormone (LH), or progesterone or a metabolite [par. 8, 38].
Regarding claim 29, Heikenfeld further teaches using at least two urine-based LH test strips to indicate a time for use of the system, and wherein the system continuously measures at least LH for at least 6 hours [par. 9].
Regarding claim 30, Heikenfeld further teaches the system continuously measures at least LH for at least 24 hours [par. 9].
Regarding claim 31, Heikenfeld further teaches taking at least one measurement of progesterone, or a metabolite thereof [par. 8, 38].
Regarding claim 32, Heikenfeld further teaches the system continuously measures LH and progesterone for at least 6 hours [par. 10, 38]
Regarding claims 33 and 34, Heikenfeld further teaches providing continuous concentration data of at least one hormone and/or analyte measured, a predicted time of ovulation, a predicted time of peak fertility, and a confirmation that ovulation has occurred, or any combination thereof [par. 10, 40].
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Heikenfeld and in further view of Beckley (U.S. Patent Application Document 2020/0141953)
Beckley was submitted in Applicant’s IDS
Regarding claim 39, Heikenfeld teaches method of predicting and/or confirming ovulation, as disclosed above
However, Heikenfeld does not teach the metabolite of progesterone is pregnanediol
Beckley teaches the metabolite of progesterone is pregnanediol [par. 57].
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Heikenfeld, to incorporate the metabolite of progesterone is pregnanediol, for allowing the results to be visually interpreted with the naked eye, as evidence by Beckley [par. 57].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GRACE L ROZANSKI whose telephone number is (571)272-7067. The examiner can normally be reached M-F 8:30am-5pm, alt F 8:30am-5pm.
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/GRACE L ROZANSKI/Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791